Medical Director - Dermatology

IQVIA•Durham, NC

About The Position

The Associate Medical Director - Dermatology provides medical, clinical, and scientific advisory expertise to IQVIA divisions as requested. The role participates in Medical Science activities on assigned trials, serves as a medical expert throughout project delivery, and provides therapeutic and medical expertise to business development activities. Primarily serving as a Global Medical Advisor, the position advises project leaders, supports investigative sites and project teams with protocol-related questions and patient safety or eligibility issues, and conducts medical reviews of trial documents, adverse events, and study reports. The role also provides therapeutic-area training and may collaborate with Pharmacovigilance on serious adverse event reviews and analyses.

Requirements

Be available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at investigative sites.
Excellent communication, presentation, and interpersonal skills, including command of written and spoken English.
Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
Dermatology certification is mandatory.
Specialty Board certification is required.
At least 5 years of clinical medicine experience, in addition to 4 years of clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry.
Robust and current knowledge of the scientific, clinical, regulatory, commercial, and competitive landscape in the applicable therapeutic area.
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
Excellent consultation and advisory skills across multiple assignments, as well as initiative and flexibility.

Responsibilities

Serve primarily as Global Medical Advisor on assigned projects.
Act as Scientific Advisor and guide Project Leaders on the medical and scientific aspects of assigned projects.
Provide medical support to investigative sites and project staff on protocol-related issues, including protocol clarifications, inclusion and exclusion determinations, and patient safety or eligibility issues.
Review protocols, Investigative Drug Brochures (IDBs), and/or Case Report Forms (CRFs).
Review and clarify trial-related adverse events.
Provide therapeutic-area and indication training for project clinical teams.
Attend and present at Investigator Meetings.
May conduct medical case reviews of Serious Adverse Events (SAEs), including case documentation and patient narratives, in collaboration with Pharmacovigilance.
May provide medical support for Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance.
May review adverse event coding.
Review Clinical Study Reports (CSRs) and patient narratives.
Attend Kick-Off meetings, weekly team meetings, and client meetings as needed or requested.
Provide medical, clinical, and scientific advisory expertise to IQVIA divisions as requested.
Participate in Medical Science activities on assigned trials and provide therapeutic and medical expertise to business development activities.